The Pharmaceutical Risk Management (1 Day) Training course provides individuals with the chance to investigate how important risk management has now become to the healthcare industry.

People will have the opportunity to view the regulatory viewpoint, associated guidance and have the chance to try using different tools and techniques on case study activities.

• Identify why Risk Management has become important in the regulatory world of healthcare manufacturing
  • Flexible regulatory approach: companies can now determine the most appropriate decisions and actions to take
• Interpret the International Conference for Harmonisation Q9/Annex 20 guidance document
  • Clarification of the EU and FDA perspective
• Learn how Risk Management could work for your organisation
  • Determine the success criteria for utilising Risk Management
  • Risk Management teams, roles, strong leadership, documentation and likely pitfalls
• Consider different methods and documentation for applying Risk Management to daily operations, including FMEA and the GAMP®  approach
  • A summary of different approaches to Risk Assessment methods and focus of use giving examples of FMEA and GAMP®’s approach
• Apply Risk Assessment methods to different case study scenarios, for individual selection such as:-
  • Applicability and focus of SOPs/documentation
  • Continuous improvement projects
  • Equipment and computer systems validation, including electronic records and signatures
  • Purchasing/materials and components
  • Change control including
  • Training including revision requirements for SOPs
  • Quality Management Systems e.g. CAPA, auditing focus etc
  • Production operations
  
  
  

  ISPE owns the GAMP® trademark http://www.ispe.org/

This course can be delivered to a group of up to 12 delegates at your premises. Request a quote for an onsite course.

ITS offers onsite training courses delivered by an English-only speaking trainer for companies in Europe and Worldwide. ITS has delivered courses to delegates from a number of countries including Belgium, France, Germany, Ireland, Jordan, Russia, Sweden and Switzerland.

"Course material and examples very relevant to pharmaceutical filling and packaging - just what I needed."
Napp Pharmaceuticals Ltd

“A new area for me so I have learned when to apply QRM techniques within my department.”
Controlled Therapeutics

“Case studies were especially helpful.”
Controlled Therapeutics
 
“Well presented, trainer provided information when asked questions.”
Open course delegate

“Good course well presented and good size of group.”
Open course delegate

“Well designed course.”
Sanofi Aventis

ITS’ Regulatory Training Manager, Alan Benbow, has developed extensive knowledge of this specialist area from 22 years’ industry experience working with Johnson & Johnson, and Wyeth Pharmaceuticals.

During his 14 years at Wyeth, Alan was involved in a wide range of activities including, at operational levels, developing operators, craftsmen, and technicians; he was also responsible for training and assessing operational employees to NVQ standards. From a mid-management perspective, training and development initiatives included facilitating continuous improvement projects and best practices, and receiving internal recognition awards. more ›